National Pregnancy Registry to Study Safety of Psychiatric Medications During Pregnancy Tracking Effects on Mothers and Babies

What this Trial Is About

Researchers are evaluating the safety of various psychiatric medications taken during pregnancy, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics. The goal is to gather detailed information on whether these medications increase the risk of major birth defects or affect neonatal outcomes, as current data is limited. This observational study aims to better understand risks for infants exposed to psychiatric medications in the womb and maternal health outcomes associated with their use during pregnancy. Pregnant women taking these medications are grouped based on the type of psychiatric drug they have used, such as atypical antipsychotics, antidepressants, ADHD medications, sedative hypnotics, or other psychiatric medications. The study collects data prospectively and systematically throughout pregnancy and postpartum periods. Specific medications of interest include well-known brands like Abilify, Seroquel, Spravato, and Qelbree, among others. Participants provide information over the phone and consent to ongoing monitoring of pregnancy and infant health. Researchers assess major malformations in infants up to one year of age, tracked through medical records and postpartum interviews. They also evaluate various maternal and neonatal outcomes, including gestational weight gain, birth outcomes, neonatal complications, and child developmental assessments at multiple time points up to five years. The study lasts from pregnancy through early childhood follow-up, with detailed data collection at key intervals.

National Pregnancy Registry for Psychiatric Medications